RAYSCAN A-EXPERT 3D— 510(k) K122981
Substantially EquivalentRay Co., Ltd.
FDA 510(k) clearance K122981 for RAYSCAN A-EXPERT 3D, Substantially Equivalent on 2013-03-12. Applicant: Ray Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Ray Co., Ltd.
- Product code
- Code OAS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1750
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Beverly Hills, CA, US
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